Double Blind Placebo Controlled Evaluation of Clinical Activity and Safety of Dation 500 mg in the Treatment of Acute Haemorrhoids

Abstract

Objective: Efficacy of treatment of acute haemorrhoidal crisis by Daflon 500 mg (D500) in comparison to a placebo (Pl). Design: Prospective, double blind, placebo controlled trial with randomization into two parallel groups. Setting: In- and outpatients at a University Hospital. Patients: One hundred patients with a history of haemorrhoidal disease, suffering from an acute haemorrhoidal attack. Interventions: Administration of Daflon 500 mg or placebo at a dose of three tablets b.i.d. for the first 4 days and two tablets b.i.d. for the following 3 days. Main outcome measures: Improvement of symptoms and signs measured by a score and patient acceptability. Results: Overall improvements of symptoms was greater in the D500 group than in the Pl group, from day 2 up to day 7. The clinical severity of proctorrhagia, anal discomfort, pain and anal discharge diminished in both groups, but to a greater extent in the D500 group ( p <0.001). Inflammation, congestion, oedema and prolapse were more markedly improved in the D500 group than in the Pl group. Duration and severity of the current haemorrhoidal episode, as assessed by patient self-evaluation, were less important in the D500 group compared with previous episodes. Use of analgesics and topical medications diminished in both groups, with a major reduction in the D500 group from day 4 ( p <0.001). Acceptability was good in both groups: no patient experienced major side-effects. Conclusion: Treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute haemorrhoids than with the placebo.